13 days old

Global Clinical Program Management Senior Manager Observational Research

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117895913
Amgen

Job ID: R-92044
Location: Thousand Oaks, CA, US 91360
Additional Location: United Kingdom - Cambridge, United Kingdom - Uxbridge

Global Clinical Program Management, Observational Research as part of Global Development Operations, plays a meaningful role in ensuring the efficient and successful planning and execution of observational research studies globally, throughout the drug development lifecycle. The evidence generated through this observational research is used to support the value of Amgen's medicines.

Reporting to the Director, Global Clinical Program Management (GCPM) for Observational Research, the Senior Manager, GCPM Observational Research, is an expert and skilled member of the GCPM team and collaborator across the Global Development organization, Medical and other key internal and external stakeholders. This role will be located on the Amgen corporate campus in either Thousand Oaks, California or UK (Uxbridge or Cambridge).

Responsibilities:

Supports GCPM Director in the following activities:
  • Operational strategy, planning, risk assessment and mitigation, and overall execution for the observational research (OR) portfolio
  • High-quality execution of OR studies on time and within budget
  • Provide leadership and expertise on the regional Key Evidence Generation Teams (KEGs) and Evidence Generation Teams (EGTs)
  • Provide clinical operations leadership and expertise through the feasibility and study design process
  • Ensure compliance with Good Clinical Practice (GCP), Amgen SOPs and any applicable legislation
  • Maintain and improve global teamwork and consistency
  • Lead observational clinical study process development activities, including authoring and/or review of SOPs, Manuals, trainings and cross functional workstreams
  • Support GCPM resource planning for GCPM-OR in collaboration with Project Resourcing Lead and GCPM-Director


Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 2 years of Clinical experience

OR

Bachelor's Degree and 4 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

Or

High school diploma / GED and 12 years of Clinical experience

Preferred Qualifications:
  • BS/BA/BSc in the sciences or RN
  • 9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
  • Experience conducting and/or leading all aspects of observational research execution in an industry setting
  • Previous management experience of direct reports
  • Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc)
  • Experience driving and leading process development and /or improvement


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Work alongside the best. Be part of our highly hardworking teams. Their spirit is what fuels our success.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI117895913

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92044<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>United Kingdom - Cambridge, United Kingdom - Uxbridge<br/><br/>Global Clinical Program Management, Observational Research as part of Global Development Operations, plays a meaningful role in ensuring the efficient and successful planning and execution of observational research studies globally, throughout the drug development lifecycle. The evidence generated through this observational research is used to support the value of Amgen's medicines.<br><br>Reporting to the Director, Global Clinical Program Management (GCPM) for Observational Research, the Senior Manager, GCPM Observational Research, is an expert and skilled member of the GCPM team and collaborator across the Global Development organization, Medical and other key internal and external stakeholders. This role will be located on the Amgen corporate campus in either Thousand Oaks, California or UK (Uxbridge or Cambridge).<br><br>Responsibilities:<br><br>Supports GCPM Director in the following activities:<br><ul><li>Operational strategy, planning, risk assessment and mitigation, and overall execution for the observational research (OR) portfolio</li><li>High-quality execution of OR studies on time and within budget</li><li>Provide leadership and expertise on the regional Key Evidence Generation Teams (KEGs) and Evidence Generation Teams (EGTs)</li><li>Provide clinical operations leadership and expertise through the feasibility and study design process</li><li>Ensure compliance with Good Clinical Practice (GCP), Amgen SOPs and any applicable legislation</li><li>Maintain and improve global teamwork and consistency</li><li>Lead observational clinical study process development activities, including authoring and/or review of SOPs, Manuals, trainings and cross functional workstreams</li><li>Support GCPM resource planning for GCPM-OR in collaboration with Project Resourcing Lead and GCPM-Director</li></ul><br><br>Basic Qualifications:<br><br>Doctorate Degree<br><br>OR<br><br>Master's Degree and 2 years of Clinical experience<br><br>OR<br><br>Bachelor's Degree and 4 years of Clinical experience<br><br>OR<br><br>Associate's degree and 10 years of Clinical experience<br><br><b>Or</b><br><br>High school diploma / GED and 12 years of Clinical experience<br><br>Preferred Qualifications:<br><ul><li>BS/BA/BSc in the sciences or RN</li><li>9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company</li><li>Experience conducting and/or leading all aspects of observational research execution in an industry setting</li><li>Previous management experience of direct reports</li><li>Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc)</li><li>Experience driving and leading process development and /or improvement</li></ul><br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Work alongside the best. Be part of our highly hardworking teams. Their spirit is what fuels our success.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/m6DYkYFM1EPZcKlqs4m2Z"> <p>PI117895913</p>

Categories

Posted: 2020-02-08 Expires: 2020-03-10

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Global Clinical Program Management Senior Manager Observational Research

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast